Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856271
• Other study ID #: SS-866/01
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2009
• Last updated: September 28, 2010
• Start date: August 2004
• Est. completion date: April 2005

Study information

• Verified date: September 2010
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: April 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• mild to moderated essential hypertension (mean seated diastolic blood pressure = 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)

• able to give written informed consent

Exclusion Criteria:

• known or suspected secondary hypertension

• history of chronic hepatic diseases

• obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease

• cardiac arrhythmia

• unstable angina pectoris

• congestive heart insufficiency (New York Heart Association classification III-IV)

• bilateral renal artery stenosis

• isolated renal artery stenosis

• post renal transplantation

• history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment

• retina bleeding/effusion

• insulin dependent diabetes mellitus

• uncontrolled non-insulin dependent diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• olmesartan medoxomil
oral tablets, once daily for 8 weeks
• losartan potassium
capsules, once daily for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.	Shanghai Sankyo Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of trough seated diastolic blood pressure from baseline to 8 weeks		Baseline to 8 weeks	No